# K073322: Fox 1-980, Fox Q-1064, Fox-Q-810

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C Laser GmbH
- Decided: Feb 22, 2008 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 175 ancestors in all.
22 later devices descend from it; 6 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062619: Denlaser 800 Plus, CAO Group, Inc. (2006) Summary page 1.
- K072106: 150W Ceralas D 980NM Diode Laser, Biolitec, Inc. (2007) Summary page 1.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.

## Most influential descendants
- K193656: SkyPulse (2020), 11 descendants of its own
- K091562: Doctor Smile a-810 and B-980 Lasers (2009), 8 descendants of its own
- K102036: Doctor Surgery Diode Lasers Family (2010), 7 descendants of its own
- K122567: Joule 810/940/980 Multi-Platform System (2013), 6 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own

## Indications for use
Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology. Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery. Fox Q-1 064: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Source page: https://510kreport.com/device/K073322
Methodology: https://510kreport.com/methodology